Technical Project Manager

Job Description

Nature and Scope

The R&D Technical Project Team Leader will provide technical, programmatic and alliance leadership for New Product Portfolio. Define & implement scientifically sound, customer-centric & business-driven R&D project strategy including risk management planning in line with project goal/objectives. Convert strategy into feasible project plan & assure timely updates with critical path activities. Present & secure governance endorsement of strategy. Represents R&D at cross-functional forums & contribute to the overall team strategy by ensuring the integrated R&D strategy is incorporated & in line with the team objectives/deliverables.

Essential Duties and Responsibilities

Nothing in this job description restricts managements right to assign or reassign duties and responsibilities to this job at any time.

Technical and Strategic leadership on Portfolio execution for all phases of product development starting from Molecule Selection, Project Feasibility, Analytical/Formulation/Process Development, Exhibit batch manufacturing, Stability testing, FDA submission support, and Product Launch activities.

Leads R&D project teams and represents R&D at cross functional forums and contribute to the overall team strategy by ensuring the integrated R&D strategy is incorporated and in line with the team objectives/deliverables.

Define and implement a scientifically sound, customer centric & business-driven R&D project strategy including risk management planning in line with project goals/objectives; convert strategy into feasible project plan & assure timely updates with critical path activities identified.

Dictates scope and direction, guides, reviews, and approves analytical development and formulation/process development work, ensuring robust pharmaceutical development and data available to support subsequent filings.

Ensures all CMC requirements are met and maintained through development, manufacturing, and filing by closely collaborating with regulatory, production, and quality units.

Negotiates end-to-end technical requirements and associated timelines, costing and resource utilization.

Conducts due diligence and gap assessment to identify critical path issues, risks and mitigation plan.

Ensure Project Team is effectively managed including meeting management; template and presentation creation, supply & quality topics regularly discussed & documented; ensure timely, comprehensive & concise project documentation.

Provide accurate cost, time and resource estimates needed for an integrated CMC development plan. Ensure 100% utilization of capabilities, resources and assets.

Proactively communicate critical and key issues as well as any other relevant topics to the appropriate management level and project team members.

Ensure timely availability of agreed deliverables, no delay in stage gate approvals due to R&D misses, proactively manage all activities between R&D & external departments (e.g. PMO, Commercial, Portfolio, Legal, Manufacturing, Quality, Regulatory, Clinical, 3rd party), no delay in handovers and launches, project milestones and transitions fully supported.

Provide strong input into the performance review of team members, recognition of people/team accomplishments through informal & formal recognition programs/activities.

Presents to senior leadership and executives on project status, including risks and mitigation approaches, as well as acceleration funding opportunities.

Perform any other tasks/duties as assigned by management.

Education Requirements and Qualifications

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill and/or ability required.

PhD or Masters degree in scientific field or equivalent experience required.

Minimum of 10 years of product development experience preferably in sterile injectable formulations.

2-3 Years of Program Management experience is preferred.

Knowledge of cGMPs and understanding of regulatory filing requirements.

Must have demeanor appropriate for interaction with all levels of American Regent Management and work with contract providers.

Strong written and verbal communication skills.

Superior time management and project management skills are essential.

Must have the ability to analyze and report on complex subject matter.